FDA Adverse Event
Death
Summary report: N
SENSATION PLUS 8FR 50CC
MDR report key: 4092338
·
Received September 2, 2014
Report
- Report Number
- 2248146-2014-00371
- Event Type
- Death
- Date Received
- September 2, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 4, 2014
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- PMA / PMN Number
- K112327
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS PROMISED FOR RETURN BUT HAS NOT YET BEEN RECEIVED. WHEN THE PRODUCT IS RETURNED AN EVALUATION WILL BE PERFORMED AND THE RESULTS SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED DIFFICULTIES INSERTING THE 50CC BALLOON THROUGH THE INTRODUCER. IT WAS AN EMERGENT PT AND THE SURGEON STRUGGLED WITH ADVANCING THE CATHETER. THE BALLOON WAS FINALLY INSERTED, BUT THE PT DIED IN THE CVICU POST-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 533047 | SENSATION PLUS 8FR 50CC | INTRA AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP | 0684-00-0575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |